Pure Global
210311
IV
current

Catheters, Cardiac, Septostomyๅฏผ็ฎกใ€ๅฟƒ่„ใ€้š”่†œ้€ ๅฃๆœฏ

This profile provides complete Hong Kong MDACS registration information for Catheters, Cardiac, Septostomy. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.

Product Info: Catheters, Cardiac, Septostomy

็”ขๅ“่ณ‡่จŠ๏ผš ๅฏผ็ฎกใ€ๅฟƒ่„ใ€้š”่†œ้€ ๅฃๆœฏ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
10747
Product Code Detail
10747 Catheters, Cardiac, Septostomy
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Baylis Medical Company Inc.
Baylis Medical Company Inc.
Canada
ๅŠ ๆ‹ฟๅคง
5959 Trans-Canada Highway, Montreal, Quebec, H4T 1A1, Canada
5959ๆจช่ดฏๅŠ ๆ‹ฟๅคง้ซ˜้€Ÿๅ…ฌ่ทฏ, ่’™็‰นๅˆฉๅฐ”, ้ญๅŒ—ๅ…‹, H4T 1A1, ๅŠ ๆ‹ฟๅคง
Authorised Representative (AR)
Regulatory Timeline
Registration Date
September 03, 2021
Expiry Date
September 03, 2026
Product Models
NRG Transseptal needle (NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-E-56-32-C0, NRG-E-71-C0, NRG-E-71-C1, NRG-E-89-C0, NRG-E-89-C1, NRG-E-98-C0, NRG-E-98-C1, NRG-E-HF-71-C0, NRG-E-HF-71-C1, NRG-E-HF-89-C0, NRG-E-HF-89-C1, NRG-E-HF-98-C0, NRG-E-HF-98-C1, NRG-HF-71-C0, NRG-HF-71-C1, NRG-HF-89-C0, NRG-HF-89-C1, NRG-HF-98-C0, NRG-HF-98-C1)
NRG ็ป้š”้’ˆ (NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-E-56-32-C0, NRG-E-71-C0, NRG-E-71-C1, NRG-E-89-C0, NRG-E-89-C1, NRG-E-98-C0, NRG-E-98-C1, NRG-E-E-E--HF-71-C0, NRG-E-HF-71-C1, NRG-E-HF-89-C0, NRG-E-HF-89-C1, NRG-E-HF-98-C0, NRG-E-HF-98-C1, NRG-HF-71-C0, NRG-HF-71-C1, NRG-HF-89-C0, NRG-HF-89-C1, NRG-HF-98-C0, NRG-HF-98-C1)